NIDEK SA
FR-MF-000000493 · France · SUCY-EN-BRIE
NIDEK SA is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: Consultation Unit OT-4200.
Among these devices, 12 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NIDEK CO., LTD. (JP) · FDA 8030392 |
| Devices in EUDAMED | 12 |
| Country of registration | France |